Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

January 7, 2019

Date of Report (Date of earliest event reported)

 

 

JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

 

 

Ireland   001-33500   98-1032470

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File No.)

 

(IRS Employer

Identification No.)

Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland

(Address of principal executive offices, including zip code)

011-353-1-634-7800

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On January 7, 2019, at the J.P. Morgan Healthcare Conference in San Francisco, California, Jazz Pharmaceuticals plc (the “Company”) presented a corporate overview and financial update, which presentation included the Company’s current expectations with respect to certain operating results for the year ended December 31, 2018. The presentation was announced by a widely disseminated press release and was made available to the public by audio webcast, and the slides that accompanied the presentation were made available to the public on the Company’s website. A transcript of the relevant portion of the presentation relating to the aforementioned financial update is attached hereto as Exhibit 99.1, along with a copy of the relevant slides containing such information.

The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
Number

  

Description

99.1    Portion of transcript and related slides of presentation by Jazz Pharmaceuticals plc on January 7, 2019


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
By:  

/s/ Suzanne Sawochka Hooper

  Suzanne Sawochka Hooper
  Executive Vice President and General Counsel

Date: January 7, 2019

EX-99.1

Exhibit 99.1

Relevant portion of the transcript of the oral presentation by Jazz Pharmaceuticals plc at the J.P. Morgan Healthcare Conference in San Francisco, California on January 7, 2019:

Bruce Cozadd, Chairman & CEO, Jazz Pharmaceuticals plc

 

We’ve made so much progress in 2018, which was our best year yet… in terms of revenues.

 

I will be making forward-looking statements during the presentation. Of course, actual results are subject to risks and uncertainties that are detailed in our SEC filings.

 

I will refer to 2018 guidance a number of times during this presentation. Unless I explicitly say otherwise, that guidance is as of the time we gave it on November 6th.

 

With reference to slide 4: Our revenues have more than doubled to approximately $1.9 billion last year.

 

With reference to slide 22: Xyrem had a really terrific year in 2018. We saw 9 percent volume growth year-over-year for Xyrem, and we saw our disease awareness efforts improve narcolepsy awareness and diagnosis rates. We gave guidance of $1.385 to $1.4 billion. I will tell you today we do expect we will report total sales for the full year that will be slightly above the guidance we previously gave.

 

With reference to slide 23: Turning to the hematology and oncology side, I think many of you are aware we had supply disruptions for Erwinaze during 2018, including especially in the fourth quarter. In the case of Defitelio we saw really nice growth throughout the year, very excited about how that product has been performing… We do expect that net sales for each of [Erwinaze, Defitelio and Vyxeos] will fall within the guidance that we provided in November.

 

With reference to slide 25: We’ve been seeing really robust top-line growth for the Company, with guidance of $1.86 to $1.9 billion for the year. I’ll tell you now we expect our results will come in at the upper end of that previously given guidance.

 


Relevant slides from Jazz Pharmaceuticals plc’s presentation at the J.P. Morgan Healthcare Conference in San Francisco, California on January 7, 2019:

 

LOGO

37th Annual J.P. Morgan Healthcare Conference Bruce Cozadd, Chairman and CEO | January 7, 2019 Jackie © 2019 Jazz Pharmaceuticals all rights reserved. OSA Patient


LOGO

Forward-Looking Statements “Safe Harbor” Statement Under the Private Securities Litigation Reform Act of 1995 This slide deck and the accompanying oral presentation contain forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals’ future financial and operating results, including 2018 financial guidance, 2019 goals and expectations for growth; the company’s corporate development efforts; the company’s growth strategy; future product sales and volume; planned sales and marketing and related efforts; ongoing and future research and development activities, including planned, ongoing and future clinical trials, data read-outs and pre-clinical activities; regulatory submissions, decisions and other activities, such as the potential approvals of the NDA and the MAA for solriamfetol; future product launches; the timing of such events and activities; and other statements that are not historical facts. These forward-looking statements are based on the company’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of and revenue from Xyrem® (sodium oxybate) oral solution; effectively commercializing the company’s other products and product candidates; the time consuming and uncertain regulatory approval process, including the risk that the company’s regulatory submissions, including the NDA and the MAA for solriamfetol, may not be approved by applicable regulatory authorities in a timely manner or at all; protecting and enhancing the company’s intellectual property rights; delays or problems in the supply or manufacture of the company’s products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements; government investigations and other actions, including the risk that the company may not ultimately reach a final settlement with the U.S. Department of Justice to resolve an investigation relating to the company’s support of 501(c)(3) organizations that provide financial assistance to Medicare patients; obtaining and maintaining appropriate pricing and reimbursement for the company’s products; pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in initiating or completing clinical trials; identifying and acquiring, in-licensing or developing additional products or product candidates, financing these transactions and successfully integrating acquired businesses; the ability to achieve expected future financial performance and results and the uncertainty of future tax and other provisions and estimates; and other risks and uncertainties affecting the company, including those described from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 and future filings and reports by the company. Other risks and uncertainties of which the company is not currently aware may also affect the company’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements made in this slide deck and the accompanying oral presentation are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.


LOGO

A Strong Foundation To Support Global Growth 4 >20 3 1,200 $1.9B1 Marketed R&D Innovative Experienced Revenues Products Programs Platform Employees Technologies 1 in Sleep and Multi-stage studies CombiPlex (Jazz) ~400 R&D 2018 Guidance 3 in Hematology/ in Sleep and ADC (ImmunoGen) ~400 outside U.S. Oncology Hematology/Oncology Exosomes (Codiak) 1 Guidance provided by Jazz Pharmaceuticals plc on and as of November 6, 2018. The company currently expects that, for the year ended December 31, 2018, reported total revenues will be at the upper end of the guidance range provided on November 6, 2018. Jazz Pharmaceuticals has not finalized its financial results for the year ended December 31, 2018 and actual results may differ.


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Transforming Investment Opportunity DISCIPLINED CAPITAL STRONG FINANCIAL DIVERSE AND ALLOCATION TO OPTIMIZE EXECUTION GROWING PIPELINE SHAREHOLDER RETURNS • 2018G revenues of $1.9B1 • Multiple late- and mid-stage • $4.4B deployed in corporate assets development transactions • Doubling of revenues since 2012 over past 5 years • Growing early-stage opportunities • $1.1B invested in share • Non-GAAP adjusted net repurchases since 2013 income CAGR of 15% • Potential to drive significant (2013-2017)2,5 growth • $660M in R&D investments • $2.5B of cash generation since 20134,5 (2013-2017)3 1 G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 6, 2018. The company currently expects that, for the year ended December 31, 2018, reported total revenues will be at the upper end of the guidance range provided on November 6, 2018. Jazz Pharmaceuticals has not finalized its financial results for the year ended December 31, 2018 and actual results may differ. 2 In 2Q16, Jazz modified the calculation of its non-GAAP income tax provision and effected this modification in the non-GAAP results from 2014 onwards. 3 Net cash provided by operating activities. 4 Non-GAAP adjusted R&D expense for period from January 1, 2013 through September 30, 2018. 5 Reconciliations of GAAP net income to non-GAAP adjusted net income and GAAP R&D expense to non-GAAP adjusted R&D expense can be found in the Appendix at the end of this presentation.


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1 • FDA-approved for the NET PRODUCT SALES treatment of cataplexy $ in millions and EDS in narcolepsy Nine months ended patients    $1,500 $1,385 – $1,4002 September 30 ³ 7 years of age $1,250 $1,187 • Disease awareness $1,108 efforts to improve $1,000 narcolepsy awareness and diagnosis rates $750 • Received pediatric exclusivity in October $500 2018—expect to launch pediatric indication in $250 1H19 $0 • Expect mid-single digit 2016 2017 2018G volume growth in 2019 Volume Growth    6% < 1% 9% (YOY) 1 2016 and 2017 audited; Nine months ended September 30 for 2016, 2017 and 2018, unaudited. 2 G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 6, 2018. The company currently expects that, for the year ended December 31, 2018, reported Xyrem net product sales will be slightly above the guidance range provided on November 6, 2018. Jazz Pharmaceuticals has not finalized its financial results for the year ended December 31, 2018 and actual results may differ. 22    


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Hematology/Oncology Revenues NET PRODUCT SALES1 $ in millions $250 $250 $250 $201 $197 $165- $200 $200 $145- $200 $1752 $1652 $150 $150 $134 $150 $95- $109 $1102 $100 $100 $100 $50 $50 $50 $34 $0 $0 $0 2016 2017 2018G 2016 2017 2018G 2017 2018G Nine months ended September 30 1 2016 and 2017 audited; Nine months ended September 30 for 2016, 2017 and 2018, unaudited. 2 G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 6, 2018. The company currently expects that, for the year ended December 31, 2018, reported Erwinaze, Defitelio and Vyxeos net product sales will meet the guidance range provided on November 6, 2018. Jazz Pharmaceuticals has not finalized its financial results for the year ended December 31, 2018 and actual results may differ.


LOGO

Strong Financial Execution TOTAL REVENUES1 NON-GAAP ADJUSTED NET INCOME NET CASH PROVIDED BY OPERATING $ in millions PER DILUTED SHARE4 ACTIVITIES1 (unaudited) $ in millions $12.75 – $1,860 – $13.252 $1,9002 $1,619 $11.04 $10.14 $1,488 $9.45 $1,325 $693    $592    $532    2015 2016 2017 2018G 2015 2016 2017 2018G 2015 2016 2017 12.4% 3 YR CAGR3 11.2% 3 YR CAGR3 14.1% 2 YR CAGR 1 2015, 2016 and 2017 audited. 2 G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 6, 2018. The company currently expects that, for the year ended December 31, 2018, reported total revenues will be at the upper end of the guidance range provided on November 6, 2018. Jazz Pharmaceuticals has not finalized its financial results for the year ended December 31, 2018 and actual results may differ. 3 CAGR calculations based on mid-point of guidance. 4 Reconciliations of GAAP net income to non-GAAP adjusted net income can be found in the Appendix at the end of this presentation. 25